Events

Recall of Device Recall Syngo.plaza

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74390
  • Event Risk Class
    Class 2
  • Event Number
    Z-2088-2016
  • Event Initiated Date
    2016-05-09
  • Event Date Posted
    2016-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147343
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    Software error in previous software versions in which two references for the same image may exist in the database.
  • Action
    Siemens sent an Customer Information letter dated May 10, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter with software instruction to customers informing them about an upcoming software VB10B under(SY003/16/P) update change and issue that the new software version will address. For further questions, please call (610) 448-6478.

Device

Device Recall Syngo.plaza
  • Model / Serial
    Serial Numbers: 100389, 100198, 100258, 100259, 100538, 100133, 100213, 100214, 100031, 100484, 100362, 100233, 100140, 100141, 100142, 100143, 100144, 100416, 100105, 100106, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100457, 100245, 100447, 100364, 100314, 100298, 100299, 100386, 100139, 100027, 100300, 100197, 100025, 100084 100186, 100189, 100190, 100191, 100192, 100195, 100196, 100033, 100306, 100307, 100232, 100256, 100199, 100188, 100194, 100257, 100425, 100029, 100253, 100132, 100247, 100248, 100434, 100491, 100495, 100221, 100212
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI
  • Product Description
    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA